Vice President of Regulatory, Quality and Clinical

SIGA Technologies, Inc. (Corvallis OR, USA) 26 days ago
Remote Friendly Business And Management North America Full-time

SIGA Technologies, Inc. ( is seeking a full-time (40 hours/week) experienced Vice President of Regulatory, Clinical & Quality to join the team. This position will be responsible for oversight of all Regulatory, Clinical and Quality functions and be part of the executive leadership of the Company. This position will report to the EVP, Chief Scientific Officer. Responsibilities include overseeing the company’s global regulatory, clinical and quality strategies; provide leadership in interacting with regulatory and governmental agencies; interfacing with corporate partners to develop appropriate and compliant marketing strategies; direct the functional resources related to these areas and provide ongoing, hands-on expertise. This role will require travel domestically and internationally as needed. SIGA is open to this position being based at either our corporate headquarters in New York or our R&D location in Oregon. Remote employment is also option for well-qualified candidates with the understanding that frequent in-person interactions with both the corporate and R &D personnel will be required regardless of where this individual is located. As a full-time employee, the Vice President, Regulatory, Clinical & Quality is eligible for SIGA’s full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance and paid time off.

Responsibilities for this position include:

  • Develops and implements comprehensive regulatory and clinical strategies for the company’s product(s).

  • Directs the review and provides regulatory, clinical and quality guidance on related activities, ensuring adherence to government contracts and compliance with regulatory and clinical requirements for submissions.

  • Plans and oversees activities in support of INDs, NDAs, MAAs, CTXs and other regulatory submissions.

  • Identifying, selecting and overseeing the qualification of clinical Contract Research Organizations and oversees the running of clinical studies.

  • Leads the development of international regulatory strategy, timelines, staffing and budgets.

  • Works with leadership to incorporate implications of international regulatory strategy to GxP compliance policies, regulatory filings, supply chain operations, marketing, sales and external partners.

  • Supports international sales through regulatory meetings and communication to stakeholders.

  • Reviews final study reports, manufacturing process documentation, investigator brochures, clinical study protocols, clinical trial documentation and other clinical and regulatory documentation as required.

  • Interacts with key scientific and medical personnel within and outside the company to ensure timely and accurate regulatory compliance.

  • Acts as primary liaison and coordinates meetings with FDA, EMA and other health authorities as needed, representing the company with those agencies.

  • As requested, communicates the company’s position to internal and external stakeholders.

  • Evaluation of external opportunities (e.g., new technologies) for regulatory and clinical implications.

  • Manage Regulatory, Quality and Clinical personnel in accordance with Company talent management practices.

Minimum Qualifications include:

At minimum, a Bachelor’s Degree; MD, PhD, PharmD preferred with a Regulatory Affairs Certification.

Minimum of 15 years pharmaceutical industry experience.

Minimum of 12-15 years progressive experience in Regulatory Affairs with experience filing INDs and NDAs and demonstrated interaction with high level regulatory health authorities.

Minimum 5 years clinical and quality related experience.

Experience in managing and directing a geographically dispersed team in a pharmaceutical / biotech industry setting.

The successful candidate will possess the following knowledge and abilities:

  • In depth knowledge of regulatory strategy and guidance as it applies to all phases of preclinical/clinical development (early development to Phase III).

  • Strong knowledge of GCPs, ICH and CFR.

  • Experience in guiding the Quality function and familiarity with GXPs.

  • Detail oriented and comfortable in a fast-paced, rapidly changing work environment requiring the ability to prioritize and multi-task.

  • Able to work independently as well as in groups, excellent oral and written communication skills and strong interpersonal skills.

  • Excellent analytical and presentation skills.

  • Senior managerial experience in a hands-on, small company environment.

Vice President of Regulatory, Quality and Clinical

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